DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST
FDA premarket approval P890064/S021 · decided 2010-03-31
Approval details
- PMA number
- P890064
- Supplement
- S021
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 2010-02-03
- Decision date
- 2010-03-31
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR A TRADE NAME CHANGE FOR THE HYBRID CAPTURE 2 (HC2) HIGH-RISKHPV DNA TEST AND HYBRID CAPTURE 2 (HC2) HPV DNA TEST. THE DEVICES, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST ANDDIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND ARE INDICATED FOR THE QUALITATIVE DETECTIONOF SPECIFIED TYPES OF HUMAN PAPILLOMAVIRUS (HPV) DNA IN CERVICAL SPECIMENS.
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